GlaucoCetin for Glaucoma

Overseen By Jeanne Molineaux, COA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wills Eye

Must not be taking: Antiseizure, Antiplatelet, Anticoagulants, others

Disqualifiers: Epilepsy, Uncontrolled hypertension, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medical food called GlaucoCetin to determine if it can improve vision for people with open-angle glaucoma, a condition where eye pressure can damage the optic nerve. Participants will receive either GlaucoCetin or a placebo (a look-alike with no active ingredients) for six months. The goal is to discover if daily GlaucoCetin intake can help protect and support eyesight. Individuals with open-angle glaucoma who have experienced vision loss in the center or sides of their vision might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance vision care for many.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications and supplements, such as Biotin, Ginkgo Biloba, and Citicoline, at least 3 months before starting. If you are on systemic steroids, immunomodulating agents, or certain blood thinners, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that GlaucoCetin is designed to help and protect nerve cells in the eyes of people with open-angle glaucoma. Although specific safety data from studies on GlaucoCetin is not yet available, this trial primarily aims to assess its effectiveness in improving vision and eye function. The main focus is on efficacy rather than safety.

Treatments reaching this stage have typically demonstrated some level of safety in earlier research, suggesting that serious side effects are not expected. However, researchers will closely monitor participants for any possible reactions. If GlaucoCetin had already received FDA approval for another use, it might indicate reasonable safety, but that information is not available here.

In the trial, participants will be randomly assigned to receive either GlaucoCetin or a placebo (a substance with no active ingredients). This setup helps researchers determine if any effects, including side effects, are truly due to GlaucoCetin. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GlaucoCetin for glaucoma because it represents a novel approach to treating this eye condition. Unlike traditional treatments such as eye drops or surgeries that focus on reducing eye pressure, GlaucoCetin is a medical food in capsule form designed to support eye health through nutrition. This treatment is particularly promising because it targets the underlying nutritional needs of the eye, potentially providing a new avenue for managing glaucoma, especially for those with peripheral or central visual field loss. This unique method of using a nutritional approach could offer benefits that current pressure-reducing treatments do not address, making it a hot topic in glaucoma research.

What evidence suggests that GlaucoCetin might be an effective treatment for glaucoma?

This trial will compare GlaucoCetin with a placebo in participants with primary open-angle glaucoma. Research has shown that GlaucoCetin is designed to support and protect optic nerve cells, potentially improving vision for those with glaucoma. Early results suggest that taking GlaucoCetin daily for six months can lead to changes in vision and visual acuity. Although detailed information on its efficacy remains limited, the product aims to address nerve damage and loss associated with glaucoma. By targeting these nerve cells, GlaucoCetin may help preserve vision and slow disease progression. While early signs are promising, further research is needed to fully understand its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Natasha N Kolomeyer, MD

Principal Investigator

Wills Eye Hospital

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.

Inclusion Criteria

Age of 40 to 80 years

Group 2 (Central): at least 1 paracentral point repeatedly depressed at p<1% on 24-2. Also meets the HAP criteria outlined above.

Intraocular Pressure (IOP) controlled at 2 measurements >3 months

Exclusion Criteria

You are currently using nitroglycerin medication.

You have an eye condition that could make it difficult to accurately measure your eye pressure.

Visually significant retinal pathology affecting vision in past or active (such as diabetic retinopathy or age related macular degeneration)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GlaucoCetin or placebo for 6 months to evaluate changes in vision and visual function

6 months

Multiple visits for visual field testing, OCT, and other assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GlaucoCetin
• Placebo

Trial Overview The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.

How Is the Trial Designed?

Group I: GlaucoCetin Peripheral Group Active Control 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group II: GlaucoCetin Central Group Active Control 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group III: Placebo Peripheral Group Placebo Group 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Group IV: Placebo Central Group Placebo Group 1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Guardian Health Sciences, Inc.

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

The safety profile of glaucoma medications is crucial for treatment adherence, as side effects can lead to patients not following their prescribed therapy.

Long-term use of glaucoma eyedrops, especially those with preservatives, can cause ocular surface changes and systemic effects, highlighting the need for careful selection of medications and patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. Detry-Morel, M.[2018]

In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among users.

The most commonly prescribed medications, including timolol and latanoprost, showed comparable tolerability, with only a 9% chance of patients needing to change their medication due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. Beckers, HJ., Schouten, JS., Webers, CA., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-glaucoma-1-2021-1cec1

GlaucoCetin for Glaucoma · Info for Participants In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26526633/

A Systematic Review and Network Meta-analysis - PubMed Conclusions: All active first-line drugs are effective compared with placebo in reducing IOP at 3 months. Bimatoprost, latanoprost, and travoprost are among the ...

3. ctv.veeva.com ctv.veeva.com/study/vision-preservation-and-restoration-following-a-6-month-trial-of-glaucocetin

Vision Preservation and Restoration Following a 6 Month Trial ... This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1350946224000260

Addressing neurodegeneration in glaucoma: Mechanisms ... In glaucoma, a Phase I clinical trial in 11 primary open-angle glaucoma (POAG) patients showed no safety concerns after intravitreal injection of NT-501 CNTF ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9905873/

Niacinamide and Neuroprotection: The Glaucoma Holy Grail The primary outcome measure is the change in visual field progression over 2 years. The NR as a Neuroprotective Therapy for Glaucoma Trial is also a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04784234

Vision Preservation and Restoration Following a 6 Month ... The primary objective of this study is to evaluate the improvement in vision and visual function during a 6 month trial of GlaucoCetin versus placebo in ...

7. emedicine.medscape.com emedicine.medscape.com/article/1206147-overview

Primary Open-Angle Glaucoma (POAG) Over 5 years, several studies have shown the incidence of new onset of glaucomatous damage in previously unaffected patients to be about 2.6-3% ...

8. eyewiki.org eyewiki.org/Primary_Open-Angle_Glaucoma

Primary Open-Angle Glaucoma Data from the OHTS and EGPS have shown that the risk of developing POAG in these patients can be reduced by using topical therapy to lower IOP.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39509108/

Primary Open-Angle Glaucoma Polygenic Risk Score and ... Data for this report were analyzed from November 2023 to June 2024. Exposure: From 1994-2002, participants were randomized to receive topical ...